Polycystic Ovary SyndromeNCT04672720
L-carnitine and COH in PCOS Women Undergoing IVF/ICSI Cycles
A study testing L-carnitine 1000 Mg in people with Polycystic Ovary Syndrome, run by Royan Institute at 1 site in Iran.
Trial summary
The aim of this study was to evaluate the effect of oral L-carnitine supplementation during controlled ovarian stimulation (COS) in patients with polycystic ovary syndrome (PCOS) in a double-blind randomized clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- L-carnitine 1000 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2020to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 20 to 37 years old, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam's criteria who had received two to three failures of IUI cycle therapy were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months
Who cannot join
- Patients diagnosed with hyperprolactinemia, diabetes mellitus, epilepsy
- Patients treated with special diet, medication supplement (ovuboost), metformin before or during ovarian stimulation
- History of pelvic surgery on ovaries and uterus.
- Presence of submucosal and intramural fibroids larger than 5 cm or the presence of uterine polyps and congenital uterine malformations.
- The cause of severe male infertility (TESE, PESA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding L-carnitine During Ovarian Stimulation With Antagonistic Protocol in Patients With Polycystic Ovarian Syndrome on the Outcome of IVF / ICSI Cycle: A Double Blind Randomized Clinical Trial
The aim of this study was to evaluate the effect of oral L-carnitine supplementation during controlled ovarian stimulation (COS) in patients with polycystic ovary syndrome (PCOS) in a double-blind randomized clinical trial. The eligible patients with PCOS diagnosis (on the basis of Rotterdam criteria) who referred to Royan Research Institute for IVF / ICSI treatment cycles will be evaluated.
Read the detailed description
The study protocol was approved by the Institutional Review Board and Ethics Committee of Royan institute. Prior to the onset of ovarian stimulation, patients will be allocated randomly into two groups according to block randomization method. The methodologist will give the doctor a code according to the randomization list, which corresponds to the code on the drug's box, and the drug box will be delivered to the patient. The COS procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. In the experimental group, the women received 3 tablet of L-carnitine daily (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) from day 2 of the previous menstrual cycle until pregnancy test day. The patients in control group will receive 3 placebo tablets for 8 weeks. All the placebo tablets were produced by Karen company (Tehran, Iran), which is approved by the Food and Drug Administration of Iran. The appearance of the placebo was indistinguishable in color, shape, size, and smell from L-carnitine tablets. Ovarian stimulation will start with a maximum dose of 150 units of rFSH (Gonal -F: Serono Laboratories Ltd, Geneva, Switzerlan), from the second or third day of the spontaneous or discontinued progesterone menstrual cycle and the monitoring transvaginal ultrasound was performed and then if the follicle is observed, start with 13 injections of GnRH antagonist (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) and will be continued until the oocyte triggering day. From the seventh day of the cycle, the dose of rFSH will be determined according to the rate of ovarian response by vaginal ultrasonography two days in advance. If you see at least two follicles 18 mm in size or more, the final stimulation of oocyte maturation will be done and 34- 36 hour after that the ovum pickup will be conducted. Subsequently ICSI or IVF will be done with standard procedure. In the present study, the markers of insulin metabolism (fasting glucose and insulin) and lipid profiles (LDL, HDL, cholesterol and triglyceride) as well as body mass index and weight were measured at the baseline of the study (before starting L-carnitine supplementation) as well as 6 weeks later on the ovum pick up day.The outcome evaluators were also blinded to the random allocation process and type of treatment.The primary and secondary outcomes were compared between the two groups using appropriate statistical tests.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- L-carnitine 1000 Mg
- Keywords
- L-carnitine, Assisted reproductive technology, Controlled ovarian stimulation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine 1000 MgDrug
Also called Quaternary ammonium compound
Prescription 3mg l-carnitine (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) daily from day 2 of the previous menstrual cycle until pregnancy test day (approximately 8 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Adding l-carnitine to controlled ovarian stimulation antagonist protocol | Experimental | The controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. In the experimental group, the women will receive 3 tablet of L-carnitine daily (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) from day 2 of the previous menstrual cycle until pregnancy test day. Receives: Drug: L-carnitine 1000 Mg |
| Adding placebo to controlled ovarian stimulation antagonist protocol | Placebo comparator | The controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. The patients in the control group will receive 3 placebo tablets in similar way for 8 weeks. Receives: Drug: L-carnitine 1000 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occyte maturity rate
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in thepatients undergoing with ICSI.
Measured: 24 hours post oocyte retrieval day
Secondary outcomes (5)
Fertilization rate
Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization.
Measured: 48 hours post IVF/ICSI
Quality of obtained embryos
Embryo quality were determined according to the number of cells, the amount of fragmentation, the variation in cell size and overall symmetry (perfect, moderately asymmetric, and severely asymmetric in size and shape of the cells at Day 2 or Day 3 after oocyte retrieval:
Excellent (Day 3: 6-8 even size blastomeres with ≤10% fragmentation), Good (Day 3: 6-8 even or uneven size blastomeres with 10%-20% fragmentation), Poor (Uneven and few blastomeres with >20% fragmentation)
Measured: 48 or 72 hours after oocyte retrieval
Implantation rate
The number of gestational sacs observed at trans-vaginal ultrasonography screening at 6 weeks of pregnancy divided by the number of embryos transferred.
Measured: 1 month post embryo transfer
Clinical pregnancy rate
Clinical pregnancy rate per transfer as defined by the presence of a gestational sac with heart beat on ultrasound at 6-8 weeks of gestation
Measured: 6-8 weeks of gestation
ongoing pregnancy rate
Ongoing pregnancy was defined as a pregnancy documented by ultrasound at 20 gestational weeks that showed the presence of fetal heartbeat.
Measured: 20 weeks after the embryos transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Mar 2020
- Primary completion29 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maryam Hafezi, MD., Study director, Department of Endocrinology and Female Infertility, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672720
- Sponsor's protocol ID
- L-carnitine - PCOS- ART
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hafezi M, Arabipoor A, Ghaffari F, Vesali S, Zareei M, Hessari ZH. Adding L-carnitine to antagonist ovarian stimulation doesn't improve the outcomes of IVF/ ICSI cycle in patients with polycystic ovarian syndrome: a double-blind randomized clinical trial. J Ovarian Res. 2024 Jan 9;17(1):9. doi: 10.1186/s13048-023-01319-7.
PubMed 38191449
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding L-carnitine During Ovarian Stimulation With Antagonistic Protocol in Patients With Polycystic Ovarian Syndrome on the Outcome of IVF / ICSI Cycle: A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04672720
- Acronym / sponsor ID
- L-carnitine - PCOS- ART
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- L-carnitine, Assisted reproductive technology, Controlled ovarian stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effect of oral L-carnitine supplementation during controlled ovarian stimulation (COS) in patients with polycystic ovary syndrome (PCOS) in a double-blind randomized clinical trial. The eligible patients with PCOS diagnosis (on the basis of Rotterdam criteria) who referred to Royan Research Institute for IVF / ICSI treatment cycles will be evaluated.
Detailed description
The study protocol was approved by the Institutional Review Board and Ethics Committee of Royan institute. Prior to the onset of ovarian stimulation, patients will be allocated randomly into two groups according to block randomization method. The methodologist will give the doctor a code according to the randomization list, which corresponds to the code on the drug's box, and the drug box will be delivered to the patient. The COS procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. In the experimental group, the women received 3 tablet of L-carnitine daily (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) from day 2 of the previous menstrual cycle until pregnancy test day. The patients in control group will receive 3 placebo tablets for 8 weeks. All the placebo tablets were produced by Karen company (Tehran, Iran), which is approved by the Food and Drug Administration of Iran. The appearance of the placebo was indistinguishable in color, shape, size, and smell from L-carnitine tablets. Ovarian stimulation will start with a maximum dose of 150 units of rFSH (Gonal -F: Serono Laboratories Ltd, Geneva, Switzerlan), from the second or third day of the spontaneous or discontinued progesterone menstrual cycle and the monitoring transvaginal ultrasound was performed and then if the follicle is observed, start with 13 injections of GnRH antagonist (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) and will be continued until the oocyte triggering day. From the seventh day of the cycle, the dose of rFSH will be determined according to the rate of ovarian response by vaginal ultrasonography two days in advance. If you see at least two follicles 18 mm in size or more, the final stimulation of oocyte maturation will be done and 34- 36 hour after that the ovum pickup will be conducted. Subsequently ICSI or IVF will be done with standard procedure. In the present study, the markers of insulin metabolism (fasting glucose and insulin) and lipid profiles (LDL, HDL, cholesterol and triglyceride) as well as body mass index and weight were measured at the baseline of the study (before starting L-carnitine supplementation) as well as 6 weeks later on the ovum pick up day.The outcome evaluators were also blinded to the random allocation process and type of treatment.The primary and secondary outcomes were compared between the two groups using appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adding l-carnitine to controlled ovarian stimulation antagonist protocol | Experimental | Drug: L-carnitine 1000 MgThe controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. In the experimental group, the women will receive 3 tablet of L-carnitine daily (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) from day 2 of the previous menstrual cycle until pregnancy test day. |
| Adding placebo to controlled ovarian stimulation antagonist protocol | Placebo comparator | Drug: L-carnitine 1000 MgThe controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. The patients in the control group will receive 3 placebo tablets in similar way for 8 weeks. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 20 to 37 years old, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam's criteria who had received two to three failures of IUI cycle therapy were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months
Key exclusion criteria (5 listed)
- Patients diagnosed with hyperprolactinemia, diabetes mellitus, epilepsy
- Patients treated with special diet, medication supplement (ovuboost), metformin before or during ovarian stimulation
- History of pelvic surgery on ovaries and uterus.
- Presence of submucosal and intramural fibroids larger than 5 cm or the presence of uterine polyps and congenital uterine malformations.
- The cause of severe male infertility (TESE, PESA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitine 1000 MgAlso: Quaternary ammonium compoundPrescription 3mg l-carnitine (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) daily from day 2 of the previous menstrual cycle until pregnancy test day (approximately 8 weeks). | Drug | Adding l-carnitine to controlled ovarian stimulation antagonist protocol, Adding placebo to controlled ovarian stimulation antagonist protocol |
Primary outcome
Occyte maturity rate
Time frame: 24 hours post oocyte retrieval day
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in thepatients undergoing with ICSI.
5 secondary outcomes
Fertilization rate
Time frame: 48 hours post IVF/ICSI
Quality of obtained embryos
Time frame: 48 or 72 hours after oocyte retrieval
Implantation rate
Time frame: 1 month post embryo transfer
Clinical pregnancy rate
Time frame: 6-8 weeks of gestation
ongoing pregnancy rate
Time frame: 20 weeks after the embryos transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 38191449Hafezi M, Arabipoor A, Ghaffari F, Vesali S, Zareei M, Hessari ZH. Adding L-carnitine to antagonist ovarian stimulation doesn't improve the outcomes of IVF/ ICSI cycle in patients with polycystic ovarian syndrome: a double-blind randomized clinical trial. J Ovarian Res. 2024 Jan 9;17(1):9. doi: 10.1186/s13048-023-01319-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Hafezi, MD. study director
Department of Endocrinology and Female Infertility, Royan Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine 1000 Mg in people with Polycystic Ovary Syndrome, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occyte maturity rate (time frame: 24 hours post oocyte retrieval day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.